Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

NCT ID: NCT03774329

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2021-12-08

Brief Summary

Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Conditions

Crohn's Enteritis; Crohn Disease; Ulcerative Colitis; Chronic; Colitis (Noninfective)

Keywords

inflammatory bowel disease; physical activity; bone mineral density; pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

physical activity program

Child with an adapted physical activity program

Group Type: EXPERIMENTAL

adapted physical activity

Intervention Type: OTHER

Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.

Usual care

Group Type: OTHER

Usual care

Intervention Type: OTHER

Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.

Interventions

Usual care

Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.

Intervention Type: OTHER

adapted physical activity

Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient with IBD (Crohn's disease, ulcerative colitis or unclassified chronic colitis) since at least 6 months.
• Computer and internet access at home.
• Consent to adhere to a physical activity program.
• Assent of the child to participation in the research protocol.
• Informed consent of parents or legal guardian.
• Patient benefiting from national health.

Exclusion Criteria

• At time of inclusion, acute intercurrent events which may lead to a decrease in physical activity (according to the judgment of the investigator) as fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions.
• Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity.
• Refusal of the child to participate to the protocol.
• Refusal of one of the child's parents to participate in the protocol.
• Predictable lack of compliance to study procedures (especially to the physical activity program).
• Child with visual impairment.
• Participation in another interventional study.
• Pregnant or lactating women.
• Patient under protection of justice.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie COOPMAN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Chu Amiens Picardie

Amiens, , France

Hop Jeanne de Flandre Chu Lille

Lille, , France

Countries

France

References

Vanhelst J, Coopman S, Labreuche J, Dupont C, Bertrand V, Djeddi D, Turck D, Ley D. Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease. BMJ Open. 2020 May 18;10(5):e036400. doi: 10.1136/bmjopen-2019-036400.

Reference Type: RESULT

PMID: 32430452 (View on PubMed)

Other Identifiers

2018-A00423-52

Identifier Type: OTHER

Identifier Source: secondary_id

2017_04

Identifier Type: -

Identifier Source: org_study_id